510(k) · Cleared
ClearedWell Lead Reinforced Endotracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Instruments · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jul 10, 2008 as substantially equivalent to K032112 (Portex, Ltd., 2004) and 1 other predicate after a 220-day review. Its family tree reaches back 5 generations to 1990. 4 of the 24 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jul 10, 2008
- Review
- 220 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903730 (1990). 18 ancestors in all, the oldest K811033 (1981). 5 later devices descend from it, 3 citing it directly. 4 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
- 4 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
- 3 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
- 2 generations backK030570 Blue Line Ultra Suctionaid Tracheostomy TubePortex, Ltd. · 2003
- 1 generation backK032112 P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Portex, Ltd. · 2004
- This deviceK073383 Well Lead Reinforced Endotracheal TubeWell Lead Medical Instruments · 2008
- Descendant · cites it directly · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK140228 Disposable Tracheal TubeSuzhou Weikang Medical Apparatus Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK111406 Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever…Hangzhou Bever Medical Devices Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK190274 Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK170234 Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd. · 2018
Class I recalls in this family
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…2 generations back · 2000
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy2 generations back · 1996
- K961840 Rusch Oral/Nasal Tracheal Tube, Plain…2 generations back · 1996
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye2 generations back · 1993
Most influential descendants
Showing 5 of 5 · See all- K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017 · cites it directly1descendant
- K140228Disposable Tracheal TubeSuzhou Weikang Medical Apparatus Co., Ltd. · 2014 · cites it directly1descendant
- K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal…Hangzhou Bever Medical Devices Co., Ltd. · 2012 · cites it directly1descendant
- K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019 · 2 generations on0descendants
- K170234Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903730 | D.I.C. Tracheostomy Tubes & Laryngectomy Tubes | Concord/Portex | 1990 | — |
| −4 | K960429 | Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner… | Smiths Industries Medical Systems, Inc. | 1996 | — |
| −3 | K980466 | Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy… | Sims Portex, Inc. | 1998 | 1 |
| −2 | K030570 | Blue Line Ultra Suctionaid Tracheostomy Tube | Portex, Ltd. | 2003 | — |
| −1 | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) | Portex, Ltd. | 2004 | — |
| 0 (this device) | K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | 2008 | — |
| +1 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +1 | K140228 | Disposable Tracheal Tube | Suzhou Weikang Medical Apparatus Co., Ltd. | 2014 | — |
| +1 | K111406 | Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced… | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
| +2 | K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019 | — |
| +2 | K170234 | Endotracheal tube; Reinforced Endotracheal tube | Zhanjiang Star Enterprise Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 1 |
| 1994 | 1 | 0 |
| 1996 | 3 | 2 |
| 1997 | 2 | 0 |
| 2000 | 1 | 1 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)Summary page 2…are conformed with ISO 5361:1999(E) except the tolerance of the outside diameter. Predicate Device: K032112 - Portex Reinforced Tracheal Tube (Cuffed and Uncuffed) K042683 Well Lead Endotracheal Tube Substantial Equivalence: Well Lea… | 2004 |
| * | K042683 | Well Lead Endotracheal TubeSummary page 2…of the outside diameter. Predicate Device: K032112 - Portex Reinforced Tracheal Tube (Cuffed and Uncuffed) K042683 Well Lead Endotracheal Tube Substantial Equivalence: Well Lead Medical Instruments claims the proposed devices… | 2005 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 132 Class I recalls
- K961840Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphyRusch Intl. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 124 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · 2 generations back · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 7 of the 18 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K160694 (Tianjin Medis Medical Device Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K032112.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Well Lead Reinforced Endotracheal Tubes are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073383: Well Lead Reinforced Endotracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073383
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026